MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1

Catalog Number 305832

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe flu plus 0.25-1ml var dose 23x1 experienced misaligned scale marking.The following information was provided by the initial reporter: we have also had issues with the printed graduations on syringes being skewed, so not accurate dosing.Defects noted before drawing up.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-21.Investigation summary: a device history record review was completed for provided lot number 2012410.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, a picture of the affected sample was returned.The picture shows a syringe with epoxy on the metal cannula component.Epoxy is the adhesive used to join the cannula to the syringe.Thirty physical samples of the same lot number were also returned.The samples were examined, but no issues were detected.It has been determined that the observed issue most likely occurred due to a temporary stoppage or malfunction in the epoxy dosage machine.As a consequence, a higher amount of epoxy was added and dropped onto the affected cannula.Regarding the reported issues of black foreign matter and skewed scale markings, with the information and samples provided, we are unable to identify a cause for these issues.H3 other text : see h10.

Event Description

It was reported that the syringe flu plus 0.25-1ml var dose 23x1 experienced misaligned scale marking.The following information was provided by the initial reporter: we have also had issues with the printed graduations on syringes being skewed, so not accurate dosing.Defects noted before drawing up.

• Brand Name: SYRINGE FLU PLUS 0.25-1ML VAR DOSE 23X1
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12345284
• MDR Text Key: 267478951
• Report Number: 3002682307-2021-00420
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305832
• Device Lot Number: 2012410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 11/05/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1